This invention relates to a flexible container for materials which are normally incompatible when stored. More particularly, the invention relates to a compartmented container wherein two incompatible materials can be sterilized in the flexible container and can subsequently be readily intermixed and administered in a safe and convenient manner.
Compartmented containers for different types of materials are well known in the art. For example, in U.S. Pat. No. 3,608,709 a laminated package is provided with an intermediate seal which includes a release area to allow the two materials to intermix. In U.S. Pat. No. 3,294,227 a folded strip barrier is disclosed for a similar purpose. U.S. Pat. Nos. 3,156,352; 3,175,558; 3,744,625; and 3,983,994 illustrate internal type seals in a multi-compartment package. In U.S. Pat. Nos. 3,950,158 and 3,964,604 rupturable type barriers are indicated for compartmented containers.
In the field of intravenous therapy, such as nutritionals, it is common practice to combine at least two aqueous based solutions such as dextrose and amino acids, and deliver them to the patient in one common infusion. Due to chemical reactivity in the autoclave sterilization process or to degradation of the components over extended durations of time when mixed together, it has been necessary for the manufacturer to package the components separately. Historically, combination of the components occurs near time of use at a central hospital pharmacy. This can be a potentially hazardous procedure based on the technique used if the components of the container are exposed even briefly to the outside atmosphere. The procedure of combining the components at the hospital pharmacy require special facilities, highly trained and conscientious personnel, valuable time, and hence an added burden of cost of the hospital especially in the situation where the hospital procures at least one of the components in bulk form and batch processes a multiple number of containers at once.
The prior art does not provide a multi-compartment container for an intravenous solution which can be readily sterilized yet activated in a desired manner. This is due to the fact that there are inherent deficiencies in the prior art containers that either prevent them from being produced economically, fail to consist and function as desired or neglect to meet all end-user requirements.
It is an advantage of the present invention to provide a package separated into two compartments containing two components that would be intermixed at the time of use by means of rupturing an internal frangible member to allow the separated components to completely intermix with each other. Other advantages are a flexible intravenous solution container containing parenteral intravenous products to be intermixed and subsequently administered; a multi-compartment container wherein the means of rupturing a frangible member separating the two compartments can be consistent and controlled; a multi-compartment container that is simple in design and able to be mass produced using existing technology, commonly used fabrication equipment and applicable to a wide range of materials; a container which provides a method of intermixing at least two I.V. solutions, so that when they are combined, maintenance of sterility is assured; and a method of combining two separated components for an admixture solution that is not time consuming, does not require special facilities, or highly trained personnel to activate.